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HomeAbout BRAF V600EAbout BRAF V600E

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Unmet needTesting for BRAF mutant mCRCUnmet need in BRAF-mutant mCRCPeer perspectives in BRAF-mutant mCRCMOALabelLinkLinkLinkLinkLabelLinkLinkLinkLinkMOAMOA

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Mechanism of disease & mechanism of actionUnmet need in BRAF-mutant mCRCPeer perspectives in BRAF-mutant mCRCMOALabelLinkLinkLinkLinkLabelLinkLinkLinkLinkClinical Trial DataClinical Trial
Data

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BRAFTOVI + cetuximab + mFOLFOX6BRAFTOVI + cetuximab + FOLFIRISelect patient characteristicsOverall survivalOverall response rateOverall survivalDuration of responseLabelLinkLinkLinkLinkLabelLinkLinkLinkLinkEfficacy​​​​​Efficacy

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Trial designProgression-free survivalSelect patient characteristicsOverall survivalOverall response rateOverall survivalDuration of responseLabelLinkLinkLinkLinkLabelLinkLinkLinkLinkSafetySafety

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Adverse reactionsLaboratory abnormalitiesDose modificationsLabelLinkLinkLinkLinkLabelLinkLinkLinkLinkDosingDosing

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Clinical Trial Data

BREAKWATER is a randomized, active-controlled, open-label, multicenter, phase 3 study evaluating BRAFTOVI + cetuximab + mFOLFOX6 and BRAFTOVI + cetuximab + FOLFIRI in a separate cohort for first-line treatment of adult patients with BRAF V600E mutant mCRC.1

 BRAFTOVI + cetuximab + mFOLFOX6 BRAFTOVI + cetuximab + FOLFIRI A separate cohort of BREAKWATER evaluated the combination of BRAFTOVI + cetuximab + FOLFIRI for first-line treatment of patients with a BRAF V600E mutation1,2Trial Design

BREAKWATER is a randomized, active-controlled, open-label, multicenter, phase 3 study with a separate cohort evaluating the efficacy and safety of BRAFTOVI + cetuximab + FOLFIRI vs FOLFIRI ± bevacizumab in patients with previously untreated BRAF V600E mutant mCRC.

The major efficacy outcome measure was confirmed ORR as assessed per BICR. An additional efficacy outcome measure included DoR as assessed per BICR.1

Patients were randomized 1:1 to one of the following treatment arms:

  • BRAFTOVI 300 mg orally once daily in combination with cetuximab 500 mg/m2 IV infusion every 2 weeks and FOLFIRI [irinotecan 180 mg/m2 (90-minute IV infusion); leucovorin 400 mg/m2 (120-minute IV infusion); and 5-FU (400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours)] (BRAFTOVI + cetuximab + FOLFIRI arm)1
  • FOLFIRI [irinotecan 180 mg/m2 (90-minute IV infusion); leucovorin 400 mg/m2 (120-minute IV infusion); and 5-FU (400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours)] and bevacizumab (optional, given per Prescribing Information)1
  • Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, lost to follow-up, or death1
  • Of these patients, the median age was 62 years, 54% were female, 61% were White, 33% were Asian, 1.4% were Native Hawaiian or Other Pacific Islander, 0.7% were Multiracial, and 3.4% were not reported. 10% were Hispanic or Latino, 83% were not Hispanic or Latino, and 7% were not reported. There were no Black or African American patients enrolled in Cohort 3 of BREAKWATER. Sixty percent (60%) had baseline ECOG performance status of 01
Randomization was stratified by ECOG performance status (0 vs 1).1dMMR, mismatch repair deficient; ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; IV, intravenous; MSI-H, microsatellite instability-high; RAS, rat sarcoma virus GTPase.References:BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2026.Elez E, Yoshino T, Shen L, et al. N Engl J Med. 2025;392(24):2425-2437.ORR per BICR

For the treatment of mCRC in patients with a BRAF V600E mutation1

BRAFTOVI + cetuximab + FOLFIRI demonstrated superior ORR vs control1*

Confirmed ORR per BICR (major efficacy outcome measure)1

 ReferencesStratified by ECOG performance status at randomization. Cochran-Mantel-Haenszel test; tested at a 1-sided alpha level of 0.025.1CI, confidence interval; CR, complete response; ECOG, Eastern Cooperative Oncology Group; PR, partial response.Reference:BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2026.DoR per BICR

For the treatment of mCRC in patients with a BRAF V600E mutation1

Duration of response per BICR

DoR per BICR (additional efficacy outcome measure)1

 Reference:BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2026.Safety: ARs, Dose Modifications, & Lab AbnormalitiesAdverse reactions1Select safety profile
  • Use of BRAFTOVI is associated with the following WARNINGS and PRECAUTIONS: New Primary Malignancies, Tumor Promotion in BRAF Wild-Type Tumors, Cardiomyopathy, Hepatotoxicity, Hemorrhage, Uveitis, QT Prolongation, Embryo-Fetal Toxicity, and Risks Associated with Combination Treatment
  • Serious adverse reactions occurred in 39% of patients who received BRAFTOVI in combination with cetuximab and FOLFIRI. Serious adverse reactions in >3% of patients included febrile neutropenia (5.6%) and infusion-related reaction (4.2%)
  • Fatal gastrointestinal perforation occurred in 1.4% of patients who received BRAFTOVI in combination with cetuximab and FOLFIRI
  • The most common (≥25%) adverse reactions of BRAFTOVI when used in combination with cetuximab and FOLFIRI were nausea, diarrhea, fatigue, vomiting, alopecia, constipation, abdominal pain, decreased appetite, and rash
Adverse reactions occurring in ≥10% of patients receiving the BRAFTOVI regimen*

Other clinically important adverse reactions occurring in <10% of patients who received BRAFTOVI in combination with cetuximab and FOLFIRI were: Drug hypersensitivity, hyperkeratosis, pancreatitis, and peripheral neuropathy.

ReferencesGrades per National Cancer Institute CTCAE v4.03.1Represents multiple related terms.1Laboratory abnormalities1‡

The most common Grade 3 or 4 laboratory abnormalities (≥10%) of BRAFTOVI when used in combination with cetuximab and FOLFIRI were decreased neutrophil count, increased lipase, decreased white blood cell count, and decreased hemoglobin.

Laboratory abnormalities occurring in ≥20% (all grades) of patients receiving BRAFTOVI + cetuximab + FOLFIRI in BREAKWATER§ ReferencesThe denominator used to calculate the rate varied from 65 to 68 based on the number of patients with a baseline and at least one post-treatment value.1Grades per National Cancer Institute CTCAE v4.03.1Dose modifications or permanent discontinuation of BRAFTOVI when used in combination with cetuximab + FOLFIRI1Adverse reactions leading to dose interruptions, dose reductions, or permanent discontinuation of BRAFTOVI Duration of exposure to BRAFTOVI when used in combination with cetuximab and FOLFIRI

Among patients who received BRAFTOVI with cetuximab and FOLFIRI (N=71)1

 CTCAE, Common Terminology Criteria for Adverse Events; INR, international normalized ratio.Reference:BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2026.AR, adverse reaction; BICR, blinded independent central review; BRAF, B-Raf proto-oncogene; DoR, duration of response; FOLFIRI, fluorouracil, leucovorin, and irinotecan; mCRC, metastatic colorectal cancer; mFOLFOX6, 5-fluorouracil, leucovorin, and oxaliplatin; ORR, objective response rate; OS, overall survival; PFS, progression-free survival.References:BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2026.Elez E, Yoshino T, Shen L, et al. N Engl J Med. 2025;392(24):2425-2437.Clinical Trial Data Therapy Management Guide Download Loading

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INDICATION AND USAGE

BRAFTOVI® (encorafenib) is indicated, in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-authorized test.

Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC.


IMPORTANT SAFETY INFORMATION

Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 and FOLFIRI for recommended dosing and additional safety information.

WARNINGS AND PRECAUTIONS

New Primary Malignancies: New primary malignancies, cutaneous and noncutaneous, can occur. In the BREAKWATER trial, the following cutaneous malignancies occurred in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6: melanocytic nevus in 5.6%, skin papilloma in 3%, basal cell carcinoma in 1.3%, squamous cell carcinoma of skin in 0.9%, keratoacanthoma in 0.4% and malignant melanoma in situ in 0.4%. In patients who received BRAFTOVI in combination with cetuximab and FOLFIRI, skin papilloma occurred in 2.8% and keratoacanthoma in 1.4% of patients. Perform dermatologic evaluations prior to initiating treatment, every 2 months during treatment, and for up to 6 months following discontinuation of treatment. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Dose modification is not recommended for new primary cutaneous malignancies. Based on its mechanism of action, BRAFTOVI may promote malignancies associated with activation of RAS through mutation or other mechanisms. Monitor patients receiving BRAFTOVI for signs and symptoms of noncutaneous malignancies. Discontinue BRAFTOVI for RAS mutation-positive noncutaneous malignancies. Monitor patients for new malignancies prior to initiation of treatment, while on treatment, and after discontinuation of treatment.

Tumor Promotion in BRAF Wild-Type Tumors: In vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells exposed to BRAF inhibitors. Confirm evidence of BRAF V600E or V600K mutation using an FDA-authorized test prior to initiating BRAFTOVI.

Cardiomyopathy: Cardiomyopathy manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in ejection fraction, has been reported in patients. Assess left ventricular ejection fraction (LVEF) by echocardiogram or multigated acquisition (MUGA) scan prior to initiating treatment, 1 month after initiating treatment, and then every 2 to 3 months during treatment. The safety has not been established in patients with a baseline ejection fraction that is either below 50% or below the institutional lower limit of normal (LLN). Patients with cardiovascular risk factors should be monitored closely. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hepatotoxicity: Hepatotoxicity can occur. In the BREAKWATER trial, the incidence of Grade 3 or 4 increases in liver function laboratory tests in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6 was 2.6% for alkaline phosphatase, and 1.3% each for ALT and AST. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, the incidence of Grade 3 or 4 increases in liver function laboratory tests was 1.5% each for ALT and AST. Monitor liver laboratory tests before initiation of BRAFTOVI, monthly during treatment, and as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hemorrhage: Hemorrhage can occur. In the BREAKWATER trial, hemorrhage occurred in 34% of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6; Grade 3 or 4 hemorrhage occurred in 3% of patients. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, hemorrhage occurred in 21% of patients. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Uveitis: Uveitis, including iritis and iridocyclitis, has been reported in patients treated with BRAFTOVI. In BREAKWATER, the incidence of uveitis among patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6 was 0.4%. Assess for visual symptoms at each visit. Perform an ophthalmological evaluation at regular intervals and for new or worsening visual disturbances, and to follow new or persistent ophthalmologic findings. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

QT Prolongation: BRAFTOVI is associated with dose-dependent QTc interval prolongation in some patients. In the BREAKWATER trial, an increase of QTcF >500 ms was measured in 4% (9/226) of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, an increase of QTcF >500 ms was measured in 1.5% (1/65) of patients. Monitor patients who already have or who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QT prolongation. Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI administration. Withhold, reduce dose, or permanently discontinue for QTc >500 ms.

Embryo-Fetal Toxicity: BRAFTOVI can cause fetal harm when administered to pregnant women. BRAFTOVI can render hormonal contraceptives ineffective. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with BRAFTOVI and for 2 weeks after the final dose.

Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with cetuximab and mFOLFOX6 or FOLFIRI. Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 and FOLFIRI for additional risk information.

Lactation: Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after the final dose.

Infertility: Advise males of reproductive potential that BRAFTOVI may impair fertility.

ADVERSE REACTIONS

BRAF V600E mutation-positive mCRC, in combination with cetuximab and mFOLFOX6

  • Serious adverse reactions occurred in 46% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Serious adverse reactions in >3% of patients included intestinal obstruction (4.7%), pyrexia (3.9%), sepsis (3.4%), and abdominal pain (3.4%)
  • Fatal intestinal obstruction occurred in 0.9%, and fatal large intestinal perforation and gastrointestinal perforation occurred in 0.4% (each) in patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6
  • Most common adverse reactions (≥25%, all grades) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab), and a subset of the control arm (mFOLFOX6 ± bevacizumab), respectively were: peripheral neuropathy (64% vs 53% and 57%), nausea (54% vs 50% and 44%), fatigue (53% vs 41% and 45%), diarrhea (42% vs 50% and 44%), decreased appetite (38% vs 27% and 30%), rash (36% vs 6% and 5%), vomiting (36% vs 22% and 17%), hemorrhage (34% vs 21% and 15%), abdominal pain (32% vs 31% and 30%), arthralgia (32% vs 6% and 7%), pyrexia (29% vs 16% and 17%), and constipation (27% vs 23% and 25%)
  •  Most common laboratory abnormalities (≥10%, Grade 3 or 4) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab), and a subset of the control arm (mFOLFOX6 ± bevacizumab), respectively were: increased lipase (53% vs 28% and 23%), decreased neutrophil count (37% vs 35% and 33%), decreased hemoglobin (19% vs 6% and 7%), decreased white blood cell count (12% vs 8% and 6%), and increased glucose (11% vs 2% and 1%)

BRAF V600E mutation-positive mCRC, in combination with cetuximab and FOLFIRI

  • Serious adverse reactions occurred in 39% of patients who received BRAFTOVI in combination with cetuximab and FOLFIRI. Serious adverse reactions in >3% of patients included febrile neutropenia (5.6%) and infusion related reaction (4.2%)
  • Fatal gastrointestinal perforation occurred in 1.4% of patients who received BRAFTOVI in combination with cetuximab and FOLFIRI 
  • Most common adverse reactions (>25%, all Grades) in the BRAFTOVI with cetuximab and FOLFIRI arm compared to the control arm (FOLFIRI ± bevacizumab) were: nausea (61% vs 57%), diarrhea (55% vs 49%), fatigue (47% vs 50%), vomiting (47% vs 31%), alopecia (35% vs 22%), constipation (31% vs 29%), abdominal pain (30% vs 22%), decreased appetite (30% vs 32%), and rash (27% vs 1.5%)
  • Most common laboratory abnormalities (≥10%, Grade 3 or 4) in the BRAFTOVI with cetuximab and FOLFIRI arm compared to the control arm (FOLFIRI ± bevacizumab) were: decreased neutrophil count (30% vs 32%), increased lipase (22% vs 12%), decreased white blood cell count (20% vs 6%), and decreased hemoglobin (10% vs 3%)
DRUG INTERACTIONS

Strong or moderate CYP3A4 inhibitors: Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors, including grapefruit juice. If coadministration is unavoidable, reduce the BRAFTOVI dose.

Strong CYP3A4 inducers: Avoid coadministration of BRAFTOVI with strong CYP3A4 inducers.

Sensitive CYP3A4 substrates: Avoid the coadministration of BRAFTOVI with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. If the coadministration cannot be avoided, see the CYP3A4 substrate product labeling for recommendations.

Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI.

Avoid coadministration of BRAFTOVI with drugs known to prolong QT/QTc interval. 

Please see full Prescribing Information for BRAFTOVI. INDICATION AND USAGE

BRAFTOVI® (encorafenib) is indicated, in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-authorized test.

Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC.